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Abstract

The Hatch-Waxman Act was enacted to balance the competing interests in the pharmaceutical marketplace between brand name and generic drug manufacturers. In the twenty years since its inception, the safe harbor provision contained in § 271(e)(1), has been interpreted to provide broad protection to those involved in research activities. However, in 2003, the Federal Circuit narrowly interpreted the safe harbor provision in a move that could potentially frustrate future research and improvements on patented technologies. Merck v. Integra is currently before the United States Supreme Court, who has the challenge of unraveling the competing interests involved. In order to encourage future research and clarify this area of law, the Supreme Court should adopt the approach set forth in Judge Newman’s dissenting opinion in Integra and exempt from infringement the use of patented products in all stages of research and development related to efforts to obtain FDA approval.

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